CYB003: Deuterated Psilocin Program with FDA Breakthrough Therapy Designation

CYB003 is a proprietary deuterated psilocin molecule. Psilocin is part of a family of molecules called indoleamines that are structurally similar to neurotransmitters such as serotonin, and acts as a 5-HT2A receptor agonist.

CYB003 is a new chemical entity (NCE) and has been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of Major Depressive Disorder (MDD).

Development Status: Initiated APPROACH, the first pivotal study in Cybin’s Phase 3 PARADIGM program in participants with moderate to severe MDD

Upcoming Milestones in 2024: Initiate second pivotal study, EMBRACE around mid-2025

CYB003 received the first known Breakthrough Therapy Designation for an adjunctive tryptamine-based therapy for MDD

This designation acknowledges the significant unmet medical need for more effective treatment of MDD. It also provides validation that Phase 2 data for CYB003 shows preliminary evidence for significant clinical improvements over existing therapies.

Breakthrough Therapy Designation expedites the development pathway for CYB003 with the following benefits:

Breakthrough Therapy Designation benefits:

  • All Fast Track Designation features, including Rolling Review for NDA
  • More intensive FDA guidance and discussion, including planned clinical trials and plans for expediting manufacturing development strategy
  • CYB003 is eligible for Priority Review and Accelerated Approval
 

CYB003 is in development as an acute, adjunctive therapy, with the potential to offer the following benefits:

  • Allows for immediate treatment without waiting to withdraw from background medications
  • Prevents withdrawal symptoms, which could be severe for some patients after years of antidepressant use
  • Eliminates logistical hurdles associated with titrating off existing medications
  • Background medications could provide some benefit even if inadequate alone

Clinical Validation for CYB003 in MDD: Robust and Sustained Remission Rates up to 12 Months

12 month Data Highlights, after 2 doses of CYB003 (16 mg):

Robust, sustained improvements in depression symptoms

Mean ~23-point reduction in MADRS scores from baseline

Average baseline MADRS score was ~32

Durable response and remission rates

100% of patients were responders
71% of patients were in remission

Favorable safety and tolerability profile

All reported AEs mild to moderate; no AEs of suicidality
No AEs/SAEs reported in the 12 month follow up

Strong and Durable Effects 4 Months After 2 Doses of CYB003

Mean 22-point reduction in MADRS scores from baseline at 4 months after just two doses of CYB003

Sustained benefit 4 months after 2nd dose with 60% of patients on 12 mg and 75% on 16 mg in remission

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Discover Cybin’s complete Research and Development Progress.